Dataset Information

Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease.

ABSTRACT: PURPOSE:To evaluate the efficacy of self-retained cryopreserved amniotic membrane (CAM) in promoting corneal nerve regeneration and improving corneal sensitivity in dry eye disease (DED). METHODS:In this prospective randomized clinical trial, subjects with DED were randomized to receive CAM (study group) or conventional maximum treatment (control). Changes in signs and symptoms, corneal sensitivity, topography, and in vivo confocal microscopy (IVCM) were evaluated at baseline, 1 month, and 3 months. RESULTS:Twenty subjects (age 66.9?±?8.9) were enrolled and 17 completed all follow-up visits. Signs and symptoms were significantly improved in the study group yet remained constant in the control. IVCM showed a significant increase in corneal nerve density in the study group (12,241?±?5083??m/mm2 at baseline, 16,364?±?3734??m/mm2 at 1 month, and 18,827?±?5453??m/mm2 at 3 months, p = 0.015) but was unchanged in the control. This improvement was accompanied with a significant increase in corneal sensitivity (3.25?±?0.6?cm at baseline, 5.2?±?0.5?cm at 1 month, and 5.6?±?0.4?cm at 3 months, p < 0.001) and corneal topography only in the study group. CONCLUSIONS:Self-retained CAM is a promising therapy for corneal nerve regeneration and accelerated recovery of the ocular surface health in patients with DED. The study is registered at clinicaltrials.gov with trial identifier: NCT02764814.

SUBMITTER: John T

PROVIDER: S-EPMC5574308 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease.

John Thomas T Tighe Sean S Sheha Hosam H Hamrah Pedram P Salem Zeina M ZM Cheng Anny M S AMS Wang Ming X MX Rock Nathan D ND

Journal of ophthalmology 20170815

<h4>Purpose</h4>To evaluate the efficacy of self-retained cryopreserved amniotic membrane (CAM) in promoting corneal nerve regeneration and improving corneal sensitivity in dry eye disease (DED).<h4>Methods</h4>In this prospective randomized clinical trial, subjects with DED were randomized to receive CAM (study group) or conventional maximum treatment (control). Changes in signs and symptoms, corneal sensitivity, topography, and in vivo confocal microscopy (IVCM) were evaluated at baseline, 1 m ...[more]

PMID: 28894606

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Project description:Background: The purpose is to perform a cost effectiveness analysis amniotic membrane vs. topical medications in the use of treating dry eye disease. A cost effectiveness analysis comparing amniotic membrane?+?other topical medications to topical cyclosporine A?+?other topical medications was evaluated using accepted decision tree modeling software.Methods: TreeAge Pro 2019 software was used to evaluate the base case costs over a one year timeframe. Sensitivity analysis was performed on those variables which had the greatest effect on choosing one therapy versus the other based on cost. Monte Carlo simulation was run 1,000 times to determine the most effective, least costly alternative. Costs were evaluated from a societal level (direct?+?indirect). Quality of life utility scores were evaluated using known time tradeoffs from prior studies (scale 0-1; with 1 being perfect vision).Results: Over a one year timeframe, the base case demonstrated that amniotic membrane?+?topical medications was the less expensive alternative and provided for incremental utilities versus topical cyclosporine?+?other medications (Cost/utility: $18,275/0.78 vs. $20,740/0.74). If examining direct costs only, topical cyclosporine was the least expensive option over a one year timeframe: $4,112 vs. $10,300. Sensitivity analysis demonstrated that in order for topical cyclosporine to be the less expensive alternative the following variables would need to be:?<?68 days productivity lost;?<?$161 productivity lost/day;?>?79% of amniotic membrane implants would need to be re-implanted at month 4 (for whatever reason);?>?$2677 per amniotic membrane implant procedure (Medicare reimbursement rate);?>?96% positive response to topical cyclosporine A at month 4;?>?58% positive response to topical cyclosporine A at month 6 and;?<?54% probability clinical improvement with amniotic membrane. Monte Carlo simulation demonstrated that amniotic membrane was the less costly, most effective alternative 91.5% of the time.Conclusion: Based on improved outcomes using amniotic membrane, patient productivity was improved resulting in lower societal costs (less days lost from work). When considering the untoward effects of dry eye disease on societal costs, an improvement of the dry eye disease condition was accomplished most often with amniotic membrane.

Dataset Information

Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease.

Publications

Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease.

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